Retaining Mechanisms for Prosthetic Valves

• US 20100256751A1
• Filed: 06/18/2010
• Published: 10/07/2010
• Est. Priority Date: 06/20/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Meiri, Oded, Maisano, Francesco, Rowe, Stanton
• Granted Patent: US 8,236,049 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 2017/32004 having a laterally movable cutting member at its most distal end which remains within the contours of said end
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support stent is delivered to a position on the surface of the outflow side of a native heart valve of a patient, the support stent defining a support-stent interior. An expandable prosthetic heart valve is delivered into the native heart valve from the inflow side of the native heart valve and into the support-stent interior. The expandable prosthetic heart valve is expanded while the expandable prosthetic valve is in the support-stent interior and while the support stent is at the position on the surface of the outflow side of the heart valve, thereby causing one or more of the native leaflets of the native heart valve to be frictionally secured between the support stent and the expanded prosthetic heart valve.

Claims

1. A method of treating a deficient mitral valve, comprising:

delivering a support band to a position within a left ventricle adjacent an outflow side of a native mitral valve such that the support band surrounds at least a portion of one or more native leaflets of the native mitral valve;

delivering a prosthetic heart valve into an interior of the native mitral valve, the prosthetic heart valve comprising a collapsible and expandable stent and a valve structure formed with pericardial tissue, the prosthetic heart valve being separate from the support band; and

expanding the prosthetic heart valve within the native mitral valve so that the native leaflets of the native mitral valve are frictionally secured between the support band and an outer wall of the stent of the prosthetic heart valve.

2. The method of claim 1, wherein the support band at least partially surrounds the chordae tendinae of the mitral valve.

3. The method of claim 1, wherein the support band comprises a cord and an adjustable locking member, the adjustable locking member securing at least two portions of the cord to the adjustable locking member to form the support band.

4. The method of claim 3, wherein the prosthetic heart valve is delivered into the left ventricle before the diameter of the support band is fixed.

5. The method of claim 1, wherein the support band comprises a shape-memory metal.

6. The method of claim 1, further comprising disconnecting the support band from at least one delivery catheter once the one or more native leaflets of the native mitral valve are frictionally secured between the support band and the prosthetic heart valve.

7. The method of claim 6, wherein the disconnecting comprises cutting through material used to form the support band.

8. The method of claim 1, wherein the stent is a self-expandable.

9. A method, comprising:

forming a partial loop around at least some of the chordae tendineae of a native mitral valve with a cord of biocompatible material;

securing a locking member to at least two portions of the cord to form a closed loop;

positioning an expandable prosthetic heart valve into an interior of the mitral valve; and

expanding the expandable prosthetic heart valve, thereby causing an exterior surface of the expandable prosthetic heart valve to urge native leaflets of the mitral valve against an interior surface of the loop and to frictionally secure the expandable prosthetic heart valve to the native leaflets of the native mitral valve.

10. The method of claim 9, wherein the act of securing a locking member to portions of the cord comprises:

positioning the locking member over the portions of the cord;

advancing the locking member along the portions of the cord, thereby decreasing a diameter of the loop formed by the cord and the locking member; and

securing the locking member to the portions of the cord to form the closed loop,

wherein the closed loop has a substantially fixed diameter and an inner diameter of the closed loop is substantially equal to an outer diameter of the prosthetic heart valve when in an expanded configuration within the native mitral valve.

11. The method of claim 9, further comprising cutting through portions of the cord to release the loop formed by the cord of biocompatible material and the locking member.

12. The method of claim 9, wherein the locking member is attached to the at least two portions of the cord occurs before the expandable prosthetic heart valve is expanded.

13. The method of claim 9, wherein the act of attaching the locking member to the at least two portions of the cord occurs after expanding the expandable prosthetic heart valve.

14. The method of claim 9, further comprising:

unsecuring the locking member from the portions of the cord prior to expanding the prosthetic heart valve;

adjusting the diameter of the loop by moving the locking member along the portions of the cord; and

re-securing the locking member to the portions and forming a second loop with a substantially fixed diameter of a different size.

15. The method of claim 9, wherein the act of forming the partial loop around the chordae tendineae of the patient'"'"'s heart is performed using one or more delivery catheters inserted through the aortic arch of the patient.

16. The method of claim 9, wherein the act of forming the partial loop around the chordae tendineae of the patient'"'"'s heart is performed using one or more delivery catheters inserted through an opening in the left ventricle of the patient.

17. A method, comprising:

advancing a first end of a support band out of a distal end of a first catheter, the support band at least partially encircling the chordae tendinae of a native mitral valve;

receiving the first end of the support band in a distal end of a second catheter;

advancing a locking member over the support band to form a loop; and

adjusting a diameter of the loop formed by the support band and the locking member to a desired diameter and securing the locking member to the support band.

18. The method of claim 18, further comprising:

advancing an expandable prosthetic heart valve into the mitral valve and the interior of the loop formed by the support band and the locking member while the prosthetic heart valve is in a compressed state; and

expanding the expandable prosthetic heart valve into an uncompressed state, thereby causing one or more native leaflets of the mitral valve to be frictionally secured between the loop and the expandable prosthetic heart valve.

19. The method of claim 18, wherein the first and second catheters are advanced percutaneously through the aortic valve to provide access to the native mitral valve for delivery of the support band.

20. The method of claim 18, wherein the act of forming the loop comprises:

advancing the distal end of the first delivery catheter into the left ventricle of a patient so that a distal portion of the first delivery catheter substantially circumscribes a first half of the patient'"'"'s chordae tendineae;

advancing the distal end of the second delivery catheter into the left ventricle of the patient so that a distal portion of the second delivery catheter substantially circumscribes a second half of the patient'"'"'s chordae tendineae and so that a distal end of the second delivery catheter contacts a distal end of the first delivery catheter, thereby forming a delivery catheter junction;

advancing the first end of the support band through the first delivery catheter, across the delivery catheter junction, and into the second delivery catheter; and

retracting the first delivery catheter and the second delivery catheter from the left ventricle of the patient.